483
Hard Manufacturing Co., Inc.Hard Manufacturing Co., Inc. – FDA 483, Mar 6, 2025
Record Details
Hard Manufacturing Co., Inc. in Buffalo, NY, a medical device manufacturer, received a Form 483 with five observations. The inspection revealed significant deficiencies in process validation for welding and lathing, lack of documented in-process inspections, and inadequate corrective and preventive action procedures. Additionally, process control procedures for welding and software validation for production equipment were not established or adequately performed.
- Office
- New York District Office
- Person
View Company Profile
ID · 89119466-b6d0-4d84-b808-b1a1e17a935b
Other documents for Hard Manufacturing Co., Inc.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.